LSC have a great opportunity for a Senior QA Specialist to join the QA team in a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 6 + years of experience providing technical QA support to pharmaceutical or biotech manufacturing operations and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE ROLE:
- Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation.
- Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
- Lead Quality review and approval of validation documentation associated with new facilities and new product introduction.
- Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable.
- Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements.
- Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations.
- Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas.
- Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product introduction.
- Provide input and Quality Oversight for change control development and implementation.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- University degree in a Science-related discipline.
- Minimum of 7 years' relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing).
- In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.
- Experience working in aseptic operations, relating to vial and syringe filling.
- Understanding of principles of Validation and New Product Introduction.
- Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions).
Apply directly via this advert or contact Siobhan Cummins on 021 477 7329 if you have any more questions about this opportunity!
Please note that we are unable to provide work permit or visa sponsorship.
